The present invention is especially directed on a method for manufacturing in-the-ear hearing devices, but may also be adapted for manufacturing outside-the-ear hearing devices.
Thereby, throughout the description and claims of the present invention the following terms are used as follows:
Definitions
Hearing device
We understand under a hearing device a device for influencing human hearing. Such a hearing device may be a noise-protection device or even a noise-canceling device, a device for improving human hearing in special situations, as e.g. in noisy environment, thereby selectively communicating with one or more than one persons, music listening in a concert hall etc. Further a hearing device may be an earphone as of a hands-free communication system, or may be an earphone for consumer audio appliances.
A hearing device may thereby especially be a hearing aid device in the sense of a therapeutical device for individuals with hearing loss. As was mentioned above, the hearing device may thereby be an outside-the-ear hearing device or and especially an in-the-ear hearing device.
Retailer:
We understand under the expression xe2x80x9cretailerxe2x80x9d the instance or location, where individuals buy hearing devices.
Audio needs:
The audio needs of an individual may be therapeutical so as to remedy ill hearing behavior to the standard of normal hearing. Audio needs of an individual may also be needs for noise protection, noise canceling, improved hearing in special situations as mentioned above, good hearing characteristics for consumer audio consumption or for hands-free communication etc. Thus, audio needs may be subdivided in therapeutical and non-therapeutical needs.
Application area for a hearing device:
We understand under this term the individual""s shape of the area of his head, whereat a hearing device shall be applied to. Such application area may therefore be the ear itself, surrounding areas behind and around the ear, the ear channel with its most individual structure. Thereby, not only the shape defines for the appliance area, but also the kind of structure, be it bony or rather of soft flesh or rather of cartilage, and its appearance, be it the texture or color of the skin. Further, the application area may be co-defined by individual characteristics, as of the production of sweat and cerumen.
Non-audio needs:
Non-audio needs of an individual and in the present context are e.g. needs with respect to aesthetic appearance as of shell colouring of a hearing device, further with respect to pricing, material of the shell surface, especially where in contact with the area of application and under consideration of individual allergies etc.
Up to now especially in-the-ear hearing aid devices are manufactured in that a individual goes to a retailer, as a consultant center. Either the individual brings, in the case of therapeutical audio needs, audiological data about his ill hearing behavior to such retailer, which data have been retrieved e.g. by a specialized medical doctor. In other cases such audiological diagnostic data are retrieved directly at the consultant""s or retailer""s location as specialized in audiological diagnostics and data evaluation.
At the consultant center, normally the retailer, the individual discusses with the staff his individual needs under consideration of audiologic data, if necessary, or more generically individual""s audio needs as a first set of information. There is further discussed, where the hearing device should be placed, in the ear or outside the ear as examples, as well as the aesthetic appearance such a hearing device would probably result in.
Especially in the case of individual""s decision to order an in-the-ear hearing device it is necessary to get information about the individual""s ear channel structure as a second set of information.
This is normally done by means of taking a mould of the ear channel and then three-dimensionally scanning such mould. Normally, scanning is done by the hearing device manufacturer in context with manufacturing the hearing device. The retailer thereby sends the mould to the manufacturer altogether with further information collected, and the manufacturer returns after construction of the hearing aid device the hardware to the retailer or, more generically, to the consultant center for approval by the individual.
Very often the device is not approved by the individual e.g. due to uncomfortable fitting at the application area or due to aesthetics, which have turned out differently than foreseen in individual""s imagination, and also because the manufacturer could not exactly know the real needs of the individual.
The retailer tries to communicate to the manufacturer further information about desired amendments on the device, which are nevertheless not always precise enough to ensure the next run of manufacturing and approval to be a full success. Very often the retailer even tries to satisfy individual""s needs by experienced self-overworking of the device, especially by hand-amending the outer shell of the hearing device.
One reason for such frequent forth and back, especially of in-the-ear hearing devices, is imprecise specification of the situation as to how the mould has been taken, i.e. with respect to chin position. Another problem is that due to retailer""s own shape amendment of the hearing device the manufacturer is not informed about the finally approved and released shape, so that a replacement necessitates a complicated trial-and-error procedure, especially if the individual changed to another consultant or retailer.
It is an object of the present invention to remedy the cited drawbacks of individual hearing device manufacturing.
This is reached according to the present invention by the method of manufacturing a hearing device individually and for an individual comprising the steps of conceiving the hearing device as a function of
first information about individual audio needs;
second information about three-dimensional shape of the application area for the hearing device at the individual;
third information about individual non-audio needs for the hearing device;
fourth information about feasibility of hearing devices,
thereby three-dimensionally visualizing the concept of the hearing device computer-based to the individual and amending said concept as visualized controlled by said individual, and freezing data defining for said concept of said device as conceived on approval by said individual or by a person authorized by said individual for subsequent realization of hearing device hardware.
Thereby, just from the beginning of conceiving the hearing device for the individual, be it a new hearing device, or be it, e.g. on repair, or on amending a hearing device, the individual and/or a person authorized by said individual is most involved in the construing procedure in that he monitors on a visualizing screen his personal hearing device as it progresses in construction. The individual may thereby influence by his individual needs and by communicating such needs finally to a conceiving computer system, the construction of the hearing device, and it is only when the individual approves the visualized concept of his future hearing device that the collected data is readied for a hardware production step.
In a first preferred embodiment of the inventive method visualizing and conceiving the hearing device as a function of the above mentioned first to fourth information is performed at one local computer system, i.e. centralized. Thereby, one and the same computer system provides not only for the visualization ability, but also for the computer power for three-dimensionally representing and calculating, e.g. by vector-graphic representation, the hearing device as a function of the said information input to such centralized computer.
In a second and even more preferred embodiment visualizing and conceiving the hearing device, again as a function of the first to fourth information, as mentioned above, is realized at more than one decentralized computer system, which systems are in mutual communication. Once the visualizing data are computed for mere visualization, there suffices a slave computer as a laptop, the screen of a PDA or even the screen of a handy to visualize the conceived hearing device to the individual.
In a further preferred mode at least two decentralized computer systems are in real-time communication, so that at each of the computers there may sit a staff member who is specialized in a specific topic, as e.g. in shell-making, in functional module-assembling, in interpreting audiological data etc.
Thus, one or more than one expert join in with the individual to conceive his personal hearing device.
Also it is absolutely possible that the individual, e.g. at home, conceives his future hearing device on a visualizing screen, thereby preferably in online communication with consulting experts at one or more than one computers systems or even in oral phone communication with a consultant, in a most preferred embodiment of the present invention, visualizing the hearing device under construction and individual""s controlling is performed at the location of a consultant. Such a consultant is most preferably a hearing device retailer.
In a further preferred embodiment the first information, which is directed on audio needs of the individual, is subdivided in a subset of first information, namely about therapeutical audio needs of the individual, which information may hardly be retrieved by the individual himself. The second subset of this first information, namely about non-therapeutical audio needs, as in the case of noise protection, noise canceling etc., may well be retrieved from the individual himself, so that this second subset of information for conceiving the hearing device is directly communicated from the individual lastly to the conceiving and visualizing computer systems.
Thereby, in a preferred mode of operation at least a part of the first information, thus especially about therapeutical needs, is retrieved at a place, which is remote from visualizing the hearing device concept to the individual. Nevertheless, this part or another part of the first information may clearly be retrieved also at the place of visualization. E.g. audiological data may be retrieved at the retailer""s place as the place of the consultant, at which the individual is present when conceiving his hearing device.
Additionally or alternatively at least a part of the first information may also be retrieved from a data bank, which has been established from data of a previous hearing device of the individual. This will especially be the case if an existing hearing device of the individual is to be repaired or only parts thereof, as e.g. the shell is to be replaced.
In a further preferred mode of the inventive method the second information, i.e. the information about three-dimensional shape of the application area of the hearing device at the individual, is retrieved by taking a mould of the application area. Thereby, in a further preferred mode such mould-taking is performed either at the specialized mould center or at the location of the consultant. Thereby again, the consultant may preferably be the retailer.
Departing from such mould this mould is preferably three-dimensionally scanned, which further preferably is performed either at a mould-scanning center or at the center, where the mould has been taken or at the location of a consultant, especially of a retailer. Latter especially then, when also mould-taking has been performed at the consultant""s place.
In another preferred mode of operating the inventive method, the second information is retrieved by in-vivo scanning three-dimensionally the individuals application area. Again this is preferably performed in an in-vivo scanning specialized center or at a consultant""s place, which again may be advantageously the hearing device retailer. With respect to this second information too, it may be retrieved from a data bank, especially if the new hearing device to be conceived is based on an existing hearing device of the same individual.
In a further preferred mode of operation the fourth information, namely information about, generically spoken, feasibility of a desired hearing device, especially under technical aspects, is retrieved from at least one hearing device manufacturer. Thereby, this information is further preferably stored in a data bank, which may be located anywhere, but has preferably to be addressable from the hearing device conceiving computer system. Preferably such a data bank is nevertheless located at the hearing device manufacturer or at a consultant center, which again may be the hearing device retailer.
Once and according to the present invention the data defining for the concept of the device as conceived and approved by the individual is frozen, this data is transmitted to a hearing device hardware manufacturing center. Again such manufacturing center may be a hearing device manufacturer or may be located at a consultant center, especially if there is provided a stock of modules for constructing different hearing devices as well as for instance the ability of shell-making, e.g, by a procedure as known from rapid prototyping and as e.g. disclosed in the WO 01/05207, which is incorporated in the present description by reference and specifically with respect to shell-making.
Again, such consultant center may preferably be at a retailer""s location, so that in a preferred mode of operation of the inventive method in fact all steps for data retrieving and hearing device hardware preparing might be performed there.
The said manufacturing center, which receives the frozen data, according to an approved hearing device concept, checks, whether a hardware hearing device may or may not be construed, which exactly matches the said frozen data. Whenever such a hearing device, which exactly matches the frozen conceptual data may not be constructed at the manufacturing center, there is conceived a novel set of data of a hearing device which may be realized and wherefrom the data matches closest the frozen data.
Thereby a hardware hearing device is not yet constructed, but first the set of data for a feasible hearing device is retrieved, the data therefrom, as was said, matching the frozen data as closest as possible, possibly with a priority setting, about which of the first to fourth information according data should match closest and which are less critical.
Then these data are retransmitted finally to the individual and visualized, so that the individual may monitor on screen what a hearing device will look like, which is in fact proposed by the manufacturing center and which does not exactly match his own approved proposal.
The individual may again in a preferred mode amend such proposition up to approval and thus a new set of frozen data is retrieved and retransmitted to the manufacturing center.
Especially if the frozen data transmitted to the manufacturing center do match with the data of a feasible hearing device or do only neglectably differ therefrom, then at a manufacturing center there is produced hardware, be it a dummy of the hearing device or a functional hearing device.
In a preferred further mode such hardware, namely the dummy and/or the functional hearing device, is transmitted to the individual and thereby, practically in parallel, also the data defining for such hardware, so that the individual may try on the hardware on one hand and on the other hand get three-dimensionally the hardware, which is just on try-on displayed on the visualizing screen. There the individual may again enter amendments, if necessary, up to approval.
Such re-amended data is then retransmitted to the manufacturing center for definite (hopefully) construction of the hearing device. The hardware, which has been transmitted to the individual for try-on, is either transmitted to the manufacturing center, or, especially in case of a dummy, is either kept for further comparative try-ons after newly constructed hardware has been received or is dispatched.